FDA-Device2015-08-05Class II
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Oxysure Systems, Inc.
Hazard
Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.
Sold states
Nationwide throughout the US and Chile, Trinidad, China
Affected count
1005 units
Manufactured in
10880 John W Elliott Dr Ste 600, N/A, Frisco, TX, United States
Products
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2253-2015Don't want to check this manually?
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